Internal Audit Procedure
3 Procedure
3.1 Audit Plan/Schedule
The audit plan/schedule which is prepared by the QA&C staff and approved by In Charge PPF shall be based on the importance of the activity being audited and results of previous audits. It will be applicable to all the working shifts and shall indicate:
a) the section to be audited
b) name of the auditors
c) audit date
Timely information of the audit is to be provided to the auditor/audit team & auditee. Also all shifts of the activity are to be audited.
The frequency of carrying out audit is once a year as a minimum. The audit plan is to be updated annually by MR and he may increase the audit frequency based upon the results of previous internal audits.
3.2 The Audit Team
The Auditing Team will be comprised of trained internal auditors selected by MR from different sections, who are responsible for performing an internal audit to seek ISO 9001 compliance. Auditors are selected from a function not directly involved in the audit and have sufficient seniority in the company to reflect the importance of the audit.
3.3 Training
Auditors are trained in auditing techniques or by consultant’s external programs. MR/Administration maintain auditors training records for the whole period of employment.
3.4 Audit Preparation
The preparation of audit includes the following.
a) Collecting of all data relevant to the audit task
b) Deciding on the date and notify the auditee of an upcoming audit.
c) Handing over of relevant pages of standard checklist to auditors, the auditor may add questions if required.
d) MR briefs auditors about the requirements, audit scope, program, areas, facilities, and department to be audited. Auditors study the procedures prior to the audit
3.5 Carry out Audit
Audits are carried out against all the requirements of the specified quality systems. Each audit is conducted in accordance with the laid down procedures and plan/schedule, but unscheduled audit(s) may be conducted if desired.
a) Auditors take sample of the system and seek objective evidence that the system is functioning as prescribed.
b) Auditors always seek objective evidence when nonconformity is apparent. The occurrence discovered may be the effect and not the cause.
c) Quality Systems are to be examined to ensure that the responsibility, authority and inter-relationship of all personnel who, manage, perform and verify work affecting quality are defined.
d) Each requirement (element) of the specification to which the Quality Systems have been documented is to be examined to ensure the system covers every element/requirement and that each one is effective.
e) Procedures and work instructions are to be reviewed for completeness, adequacy and issue levels against a master list.
f) Evidence of implementation of procedures and work instructions is to be sought in the work areas being audited. The procedures and instructions are to be to the required issue and their distribution controlled.
g) Management, Specialist, Technician, Staff, Employee and Operator training and qualification records are to be examined particularly when special skills are required, to ensure that all employees are adequately trained.
h) Corrective actions which have been undertaken to clear any previous non-conformities are to be followed up.
i) Work which has been accepted is to be selected at random and examined and findings compared with the appropriate requirements, basis for acceptance and applicable issue status.
j) Where processes are involved the audit is to examine process controls and records to establish conformance with the specification.
k) Information gathered during interviews must be checked by acquiring the same information from other independent sources and checking the samples against each other for accuracy.
l) Throughout the entire audit all the evidence collected in the form of “Observations” is to be documented on the audit check list.
m) The audit team/auditor reviews all of their observations to determine which of them are to be reported as non-conformities.
3.6 Corrective Action
Upon review of the audit, the audit findings regarding non-conformities are discussed with the auditee. The auditee in turn suggests corrective plans to the auditor and decides the date on which a re-audit is to take place to verify that all non-conformities have been successfully corrected. The corrective actions are to be approved by PPF before implementation.
The team leader has the final say in cases where the legitimacy of an audit finding cannot be resolved. The auditor completes the CPA Form to initiate the corrective action. The CPA Form is kept with the MR for 3 years. The auditor verifies successful implementation of the corrective action which must be completed within the specified time period. Follow-up audits by the auditors within the time period verify that the corrective actions are being maintained.
(See QP-4.14)
3.7 Closing an Audit
Audits are closed upon completion of the audit report and successful & effective implementation corrective action.
To close the audit, the team leader/auditor prepares the internal audit report with the assistance of audit team members using observations from audit check list. It is signed by the team leader/auditor. The In Charge PPF approves the internal audit report prior to distribution and is distributed to the concerned department where nonconformity was reported and for record.
The MR maintains an audit file which includes audit plans/schedules, internal audit reports, audit check lists, non-conformity reports and records of successful clearance of agreed corrective actions.
The MR maintains an audit logbook in the PPF office. The CPA log includes Audit Non Conformance, location and agreed correction action, date of implementing corrective action, responsible person, re-auditing date and the effectiveness of the corrective action.
3.8 Review and Evaluation
Audit results are reviewed in management review meetings for evaluation and implementation of corrective and preventive action needed.